Clinical Policy: Lenvatinib (Lenvima) Reference Number: CP.CPA.251 Effective Date: Last Review Date: Line of Business: Commercial

Transcription

1 Clinical Policy: (Lenvima) Reference Number: CP.CPA.251 Effective Date: Last Review Date: Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description (Lenvima ) is an oral receptor tyrosine kinase (RTK) inhibitor against vascular endothelial growth factor receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). FDA approved indication Lenvima is indicated: Differentiated Thyroid Cancer (DTC): single agent for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC. Renal Cell Carcinoma (RCC): in combination with everolimus, for patients with advanced RCC following one prior anti-angiogenic therapy. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation that Lenvima is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Thyroid Cancer (must meet all): 1. Diagnosis of one of the following (a or b) a. Locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer; b. Medullary thyroid cancer (off-label); 2. For medullary thyroid cancer, failure to Cometriq or Caprelsa unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed 24 mg/day. B. Renal Cell Carcinoma (must meet all): 1. Diagnosis of advanced or metastatic renal cell carcinoma; 2. Failure to one of the following, unless contraindicated or clinically significant adverse effects are expereinced: Sutent, Nexavar, Votrient, Inlyta, Avastin in combination with Intron-A, Proleukin, Torisel; 3. Failure to Opdivo or Cabometyx unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 6

2 4. Must be used in combination with everolimus (Afinitor ) unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 18 mg/day. C. Other diagnoses/indications 1. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) II. Continued Therapy A. Thyroid Cancer (must meet all): 1. Currently receiving medication via a health plan affiliated with Centene Corporation or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 24 mg/day. B. Renal Cell Carcinoma (must meet all): 1. Currently receiving medication via a health plan affiliated with Centene Corporation or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 18 mg/day. C. Other diagnoses/indications(must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy CP.CPA.09 or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CYP3A4: cytochrome P450 3A4 enzyme DTC: differentiated thyroid cancer FDA: Food and Drug Administration mci: millicurie MG: milligram NCCN: National Comprehensive Cancer Network PO: by mouth QD: daily RAI: radioactive iodine RCC: renal cell carcinoma RTK: receptor tyrosine kinase VEGFR: vascular endothelial growth factor receptors Page 2 of 6

3 Appendix B: General Information In the SELECT trial, evidence of RAI-refractory disease was defined as satisfying ONE of the following criteria: o At least one measurable lesion without iodine uptake o At least one measurable lesion that had progressed (according to RECIST o version 1.1 criteria) within 12 months after RAI therapy No improvement or disease progression despite receiving RAI equivalent to cumulative activity of >600 mci National Comprehensive Cancer Network (NCCN) guidelines recommend tyrosine kinase inhibitor (TKI)-based treatment, such as Lenvima, for patients with metastatic, RAI-refractory DTC Advanced renal cell carcinoma includes relapsed disease or Stage IV and medically or surgically unresectable disease. NCCN guidelines recommend first-line agents (Sutent, Nexavar, Votrient, Inlyta, Avastin with Intron-A,Torisel) and subsequent therapy (Opdivo and Cabometyx) prior to use of Lenvima plus everolimus for treatment of advanced or metastatic renal cell carcinoma. Medullary thyroid carcinoma is an off-label NCCN compendium recommended use with a level of recommendation of 2A following progression on Cometriq or Caprelsa, after clinical trials, or in situations where Cometriq or Caprelsa is not available or appropriate. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose Nexavar (sorafenib) Locally recurrent or metastatic, progressive, DTC refractory to RAI: 400mg PO BID 800 mg/day Sutent (sunitinib) Votrient (pazopanib) Inlyta (axitinib) Torisel (temsirolimus) 400 mg PO BID 50 mg PO QD for 4 weeks followed by 2 weeks off. 800 mg PO QD 5 mg PO BID 25 mg IV once a week mg/day 800 mg/day 10 mg PO BID 25 mg/week IV; 50 mg/week IV if taking a strong CYP3A4 inducer and 12.5 mg/week IV if taking a strong CYP3A4 inhibitor. Avastin 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 Page 3 of 6

4 Drug Dosing Regimen Dose Limit/ Maximum Dose (bevacizumab) in combination with Intron A (interferon alfa-2b) 10 mg/kg IV every 2 weeks in combination with interferon alfa 3 million IU SC/IM 5 times per week up to 36 million IU SC/IM 3 times per weeks. Doses up to 20 mg/kg IV have been administered in clinical trials. Proleukin (aldesleukin, ril-2) Opdivo (nivolumab) Cabometyx (cabozantinib) Afinitor (everolimus) Caprelsa (vandetanib) Cometriq (cabozantinib) week 600,000 IU/kg IV Q8 hrs for 14 doses, repeat after a rest period of 9 days 240 mg IV infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity 60 mg PO QD 10 mg PO QD Medullary Thyroid Cancer: 300 mg PO QD Medullary Thyroid Cancer: 140 mg PO QD 600,000 IU/kg IV Q8 hrs; 18 million IU/m2/day IV has been used off-label for RCC 240 mg IV 60 mg/day PO; 80 mg/day PO if taking a strong CYP3A4 inducer and 40 mg/day PO if taking a strong CYP3A4 inhibitor 10 mg/day 300 mg/day 180 mg/day Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic. V. Dosage and Administration Indication Dosing Regimen Maximum Dose Locally recurrent or metastatic, 24 mg PO QD 24 mg PO QD progressive, radioactive iodine refractory, differentiated thyroid cancer; Medullary thyroid cancer Advanced or metastatic renal cell carcinoma 18 mg PO QD 18 mg PO QD VI. Product Availability Capsules: 4 mg, 10 mg (supplied as six 5-day blister cards) VII. References 1. Lenvima [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc; May Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 28, Page 4 of 6

5 3. Clinical Pharmacology Web site. Available at: Accessed June 28, Schlumberger M, Tahara M, Wirth LJ, et al. versus placebo in radioiodinerefractory thyroid cancer. N Engl J Med 2015; 372 (7): National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: Accessed June 13, National Comprehensive Cancer Network. Thyroid Carcinoma Available at: Accessed January 11, National Comprehensive Cancer Network. Kidney Cancer Available at: Accessed December 5, American Hospital Formulary Drug Information. AHFS Web site. Available at: Accessed June 13, 2016.Lenvima [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc; May Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template. Minor changes to verbiage and grammar. References updated. Added NCCN Compendia use for medullary thyroid cancer Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to Page 5 of 6

6 applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 6 of 6